Medical Devices Recalls

The product has the potential to be non-sterile as it was not packaged in accordance to specification.

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were Sterile.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.

A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.

Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

An error message can occur resulting in the prior studies being unavailable for viewing.

Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

Unapproved change made by the supplier.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.